WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration, Warnings and Precautions, and Clinical Studies].
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
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use of indwelling epidural catheters
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concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
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a history of traumatic or repeated epidural or spinal punctures
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a history of spinal deformity or spinal surgery
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optimal timing between the administration of ELIQUIS and neuraxial procedures is not known
[see
Warnings and Precautions
]
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions].
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions].
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ELIQUIS SUMMARY
ELIQUIS (apixaban) is a factor Xa (FXa) inhibitor.
Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation
ELIQUIS® (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery
ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
Treatment of Deep Vein Thrombosis
ELIQUIS is indicated for the treatment of DVT.
Treatment of Pulmonary Embolism
ELIQUIS is indicated for the treatment of PE.
Reduction in the Risk of Recurrence of DVT and PE
ELIQUIS is indicated to reduce the risk of recurrent DVT and PE following initial therapy.
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NEWS HIGHLIGHTS
Published Studies Related to Eliquis (Apixaban)
Initial 3-Weeks' Apixaban Versus Dual-Antiplatelet Therapy (Clopidogrel and
Aspirin) Followed by Clopidogrel Alone in High-Risk Patients with Acute
Non-Disabling Cerebrovascular Events (ADANCE): Study Protocol for a Randomized
Controlled Trial. [2014] BACKGROUND: Nondisabling cerebrovascular events represent the largest group of
cerebrovascular disease with a high risk of recurrent stroke. A recent trial
demonstrated that dual-antiplatelet therapy (clopidogrel and aspirin), compared
with aspirin monotherapy, reduced the risk of recurrent stroke and was not
associated with increased risk of hemorrhagic events...
Apixaban vs. warfarin with concomitant aspirin in patients with atrial
fibrillation: insights from the ARISTOTLE trial. [2014] CONCLUSION: Apixaban had similar beneficial effects on stroke or systemic
High-sensitivity troponin T and risk stratification in patients with atrial
fibrillation during treatment with apixaban or warfarin. [2014] events and mortality... CONCLUSIONS: Levels of hs-TnT are often elevated in patients with AF. The hs-TnT
The effects of apixaban on hospitalizations in patients with different types of
atrial fibrillation: insights from the AVERROES trial. [2013] CONCLUSION: In AVERROES, patients on apixaban therapy were less likely to be
Randomized, double-blind trial to evaluate the safety of apixaban with
antiplatelet therapy after acute coronary syndrome in Japanese patients
(APPRAISE-J). [2013] CONCLUSIONS: The bleeding profile of apixaban in Japanese patients with ACS was
Clinical Trials Related to Eliquis (Apixaban)
Bioavailability of Apixaban Crushed Tablet [Completed]
The purpose of this study is to determine whether the bioavailability of apixaban crushed
tablets suspended in water or mixed with applesauce is similar to the bioavailability of
apixaban whole tablets administered orally.
Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events [Not yet recruiting]
Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease
with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin
treatment reduced the risk of recurrent stroke and was not associated with increased
hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is
proved to be as effective as traditional anticoagulants with less risk of bleeding events.
To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized,
double-blind, multicenter, controlled clinical trial has been designed. The investigators
will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and
aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling
cerebrovascular event.
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects [Completed]
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on
Apixaban pharmacodynamics in healthy adult subjects.
Early Post-marketing Study of Eliquis (Apixaban) [Active, not recruiting]
The primary objective of the study is to identify and describe any suspected (AEs) in all
patients with NVAF treated with Apixaban, as a request of the National Center of
Pharmacovigilance (CNFV) in Mexico.
Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects [Completed]
The purpose of this study is to assess the bioavailability of Apixaban solution administered
through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to
Apixaban solution administered orally in healthy subjects
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Page last updated: 2015-08-10
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